Development of a Breastfeeding Supportive Mobile Application

NCT05655364 | Completed DMC

• 1 other identifier: DBSMA
• Study Type: interventional
• Target: 86
• Locations: 1 country
• Sites: 1

Brief Summary

This work; The aim of this study was to develop a breastfeeding-supporting mobile application and to determine the effect of this application on breastfeeding self-efficacy and outcomes of primiparous. The research is planned to be carried out in two stages. In the first phase of the research, a mobile breastfeeding application based on Breastfeeding Self-Efficacy Theory will be developed. In the second phase of the study, a single-blind randomized pre-test-post-test control group intervention study design will be used to examine the effect of this developed application on breastfeeding self-efficacy and outcomes of primiparous. The main questions it aims to answer are:

1. 1.Does the breastfeeding-supporting mobile application based on the Breastfeeding-Self-Efficacy Theory change the breastfeeding-self-efficacy of women?
2. 2.Does a breastfeeding support mobile application based on the Breastfeeding-Self-Efficacy Theory change the rate of women starting breastfeeding within the first hour after birth?
3. 3.Does a breastfeeding-supporting mobile application based on the Breastfeeding-Self-Efficacy Theory change women's time to breastfeed alone?
4. 4.Does a breastfeeding support mobile application based on the Breastfeeding-Self-Efficacy Theory change the breastfeeding duration of women?

Conditions

Breastfeeding; Self Efficacy; Postpartum

Outcome Measures

Primary Outcomes (4)

• Changing women's breastfeeding-self-efficacy

  Changing women's breastfeeding-self-efficacy with a breastfeeding-supportive mobile application intervention based on the Breastfeeding-Self-Efficacy Theory

  8 months

• Changing the rate of women starting breastfeeding within the first hour after birth

  Changing the rate of women starting breastfeeding within the first hour after birth with a breastfeeding-supportive mobile application intervention based on the Breastfeeding-Self-Efficacy Theory

  8 months

• Changing the duration of breastfeeding alone

  Changing the duration of breastfeeding alone by women with a breastfeeding-supportive mobile application intervention based on the Breastfeeding-Self-Efficacy Theory

  8 months

• Changing the breastfeeding duration of women

  Changing the breastfeeding duration of women with a breastfeeding-supportive mobile application intervention based on the Breastfeeding-Self-Efficacy Theory.

  8 months

Study Arms (2)

Experimental

EXPERIMENTAL

Other: Mobile application

No intervention

NO INTERVENTION

Interventions

Mobile application OTHER

Breastfeeding Supportive Mobile Application

Experimental

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Volunteering to participate in the study,
• Being 18 years or older (18-45 years old),
• To know how to read and write in Turkish,
• Not having a visual-hearing disability,
• to be between weeks of pregnancy,
• Being primiparous,
• Single pregnancy,
• Wanting to breastfeed,
• Not having received breastfeeding training in any period of pregnancy before,
• Using a smart phone,
• Absence of a diagnosed psychiatric illness.

You may not qualify if:

• Women carrying fetus with major anomaly,
• Women with breastfeeding contraindications,
• Women with high-risk pregnancies,
• Women who received advice from physicians not to breastfeed due to their health status, If the baby has any of the infectious or metabolic conditions specified by WHO or the Ministry of Health for which breastfeeding is contraindicated, When a baby with a birth weight of less than 2500 g is born or taken to the neonatal intensive care unit,
• When a baby with a birth weight over 2500 g is taken to the neonatal intensive care unit due to the week of birth, the mother will continue to receive information from the application, but will be excluded from the analysis.

Sponsors & Collaborators

• Eskisehir Osmangazi University: lead

Study Sites (1)

Eskisehir Osmangazi University

Eskişehir, 26040, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Breast Feeding

Condition Hierarchy (Ancestors)

Feeding Behavior; Behavior

Study Officials

• Fatma Nilüfer TOPKARA, Dr.

  Eskisehir Osmangazi University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Dr.

Study Record Dates

• First Submitted: October 26, 2022
• First Posted: December 19, 2022
• Study Start: September 5, 2022
• Primary Completion: September 30, 2023
• Study Completion: October 30, 2023
• Last Updated: August 28, 2024

Record last verified: 2024-08

Locations

TU (1)